Cocoa Supplementation, Inflammaging, and Epigenetic Aging

Augusta University

Status and phase: Active, not recruiting; Phase 4

Conditions: Aging; Inflammation; Cardiovascular Diseases

Treatments: Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Multivitamin placebo; Dietary Supplement: Multivitamin; Dietary Supplement: Cocoa extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05510375

1687423

Details and patient eligibility

About

The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement has an anti-aging effect (epigenetic aging and inflammaging) and examining these findings in the context of CVD risk factors and outcomes.

Enrollment: 21,442 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:

Inclusion Criteria:

• Provided blood samples at baseline, Year 1, and Year 2 of follow-up.
• Opted to use EMSI for longitudinal blood collections, during which seated BPs were additionally measured.

Exclusion Criteria:

• Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

21,442 participants in 4 patient groups, including a placebo group

Cocoa extract + multivitamin

Active Comparator group

Description:

Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin

Treatment:

Dietary Supplement: Cocoa extract

Dietary Supplement: Multivitamin

Cocoa extract + multivitamin placebo

Active Comparator group

Description:

Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo

Treatment:

Dietary Supplement: Cocoa extract

Dietary Supplement: Multivitamin placebo

Cocoa extract placebo + multivitamin

Active Comparator group

Description:

Cocoa extract placebo One tablet/day of multivitamin

Treatment:

Dietary Supplement: Cocoa extract placebo

Dietary Supplement: Multivitamin

Cocoa extract placebo + multivitamin placebo

Placebo Comparator group

Description:

Cocoa extract placebo Multivitamin placebo

Treatment:

Dietary Supplement: Multivitamin placebo

Dietary Supplement: Cocoa extract placebo